Life-long Monitoring of COPD in Veneto Region

Regione Veneto

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Procedure: nurse-monitoring for patients with severe COPD; Procedure: self-monitoring for patients with severe COPD

Study type: Interventional

Funder types: Other

Identifiers

NCT01513980

G. A. 250487-Veneto WP8Cl5

Details and patient eligibility

About

The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.

Full description

The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• COPD GOLD class 3-4
• Life expectance > 12 months

Exclusion criteria

• Patient unable to use the equipment provided (alone or assisted).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 3 patient groups

Control group

No Intervention group

Description:

Treatment as usual

Self monitoring for patients with COPD

Experimental group

Description:

Procedure: self-monitoring for patients with severe COPD

Treatment:

Procedure: self-monitoring for patients with severe COPD

Nurse monitoring for patients with COPD

Experimental group

Description:

Procedure: nurse-monitoring for patients with severe COPD

Treatment:

Procedure: nurse-monitoring for patients with severe COPD